Apparatus and method to repeatedly fill and purge channels of endoscope

ABSTRACT

A medical device reprocessor is operable to perform a method of cleaning an internal channel of a medical device. The method entails activating a first pump to deliver a detergent to the internal channel for a first predetermined duration, activating a second pump to deliver water to the internal channel to rinse out the detergent for a second predetermined duration, and activating a third pump to deliver pressurized air to the internal channel to purge out the water or detergent contained within the internal channel for a third predetermined duration. Subsequently, the method involves activating a fourth pump to deliver a predetermined volume of disinfectant to the internal channel, and reactivating the third pump to deliver pressurized air to purge out the disinfectant into a chamber. The method repeats filling the internal channel with detergent, water and disinfectant and the subsequent purging of the internal channel with pressurized air.

BACKGROUND

The below discussion relates to the reprocessing (i.e., decontamination)of endoscopes and other instruments that are used in medical procedures.In particular, the below discussion relates to an apparatus and a methodthat may be used to reprocess a medical device such as an endoscopeafter the medical device has been used in a first medical procedure,such that the medical device may be safely used in a subsequent medicalprocedure. While the below discussion will speak mainly in terms of anendoscope, it should be understood that the discussion may also equallyapply to certain other medical devices.

An endoscope may have one or more working channels or lumens extendingalong at least a portion of the length of the endoscope. Such channelsmay be configured to provide a pathway for passage of other medicaldevices, etc., into an anatomical region within a patient. Thesechannels may be difficult to clean and/or disinfect using certainprimitive cleaning and/or disinfecting techniques. Thus, the endoscopemay be placed in a reprocessing system that is particularly configuredto clean endoscopes, including the channels within endoscopes. Such anendoscope reprocessing system may wash and disinfect the endoscope. Suchan endoscope reprocessing system may include a basin that is configuredto receive the endoscope, with a pump that flows cleaning fluids overthe exterior of the endoscope within the basin. The system may alsoinclude ports that couple with the working channels of the endoscope andassociated pumps that flow cleaning fluids through the working channelsof the endoscope. The process executed by such a dedicated endoscopereprocessing system may include a detergent washing cycle, followed by arinsing cycle, followed by a sterilization or disinfection cycle,followed by another rinsing cycle. The sterilization or disinfectioncycle may employ disinfectant solution and water rinses. The process mayoptionally include an alcohol flush to aid displacement of water. Arinsing cycle may be followed by an air flush for drying and storage.

Examples of systems and methods that may be used to reprocess a usedendoscope are described in U.S. Pat. No. 6,986,736, entitled “AutomatedEndoscope Reprocessor Connection with Integrity Testing,” issued Jan.17, 2006, the disclosure of which is incorporated by reference herein;U.S. Pat. No. 7,479,257, entitled “Automated Endoscope ReprocessorSolution Testing,” issued Jan. 20, 2009, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 7,686,761, entitled“Method of Detecting Proper Connection of an Endoscope to an EndoscopeReprocessor,” issued Mar. 30, 2010, the disclosure of which isincorporated by reference herein; and U.S. Pat. No. 8,246,909, entitled“Automated Endoscope Reprocessor Germicide Concentration MonitoringSystem and Method,” issued Aug. 21, 2012, the disclosure of which isincorporated by reference herein. An example of a commercially availableendoscope reprocessing system is the EVOTECH® Endoscope Cleaner andReprocessor (ECR) by Advanced Sterilization Products of Irvine, Calif.

Some versions of reprocessing systems may provide just a single use of acertain volume of disinfectant solution, such that the used volume ofdisinfectant solution is disposed of after a single use of the volume ofdisinfectant solution upon completion of the disinfection cycle. Someother versions of reprocessing system may check the concentration levelof a used volume of disinfectant solution and either re-use the useddisinfectant solution (i.e., if the concentration level is stillacceptable) or dispose of the used disinfectant solution (i.e., if theconcentration level is no longer acceptable). Examples of versions ofreprocessing systems that provide monitoring and re-use of disinfectantsolution are disclosed in U.S. Pat. No. 8,246,909, entitled “AutomatedEndoscope Reprocessor Germicide Concentration Monitoring System andMethod,” issued Aug. 21, 2012, the disclosure of which is incorporatedby reference herein; in U.S. patent application Ser. No. 15/157,800,entitled “Apparatus and Method for Reprocessing a Medical Device,” filedon May 18, 2016, the disclosure of which is incorporated by referenceherein; and in in U.S. patent application Ser. No. 15/157,952, entitled“Apparatus and Method to Measure Concentration of Disinfectant inMedical Device Reprocessing system,” filed on May 18, 2016, thedisclosure of which is incorporated by reference herein.

While a variety of systems and methods have been made and used toreprocess medical devices, it is believed that no one prior to theinventor(s) has made or used the technology as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed the present invention will be better understood from thefollowing description of certain examples taken in conjunction with theaccompanying drawings, in which like reference numerals identify thesame elements and in which:

FIG. 1 depicts a front elevational view of an exemplary reprocessingsystem;

FIG. 2 depicts a schematic diagram of the reprocessing system of FIG. 1,with only a single decontamination basin shown for clarity;

FIG. 3 depicts a cross-sectional side view of proximal and distalportions of an endoscope that may be decontaminated using thereprocessing system of FIG. 1;

FIG. 4 depicts a schematic diagram of a second exemplary reprocessingsystem;

FIG. 5 depicts a schematic diagram of a third exemplary reprocessingsystem;

FIG. 6 depicts a partial schematic diagram of an exemplary variation ofthe reprocessing systems of FIGS. 4-5;

FIG. 7 depicts a flow diagram illustrating an exemplary reprocessingmethod utilized by the reprocessing system of FIG. 6, with the internalchannels of an endoscope undergoing a repetitive disinfecting cycle withpreviously used disinfectant;

FIG. 8 depicts a partial schematic diagram of an exemplary variation ofthe reprocessing system of FIG. 1; and

FIG. 9 depicts a flow diagram illustrating another exemplaryreprocessing method utilized by the reprocessing system of FIG. 8, withthe internal channels of an endoscope undergoing a repetitivedisinfecting cycle.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

It is further understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Thefollowing-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

I. Exemplary Medical Device Reprocessing Apparatus with Single-UseDisinfectant

FIGS. 1-2 show an exemplary reprocessing system (2) that may be used todecontaminate endoscopes and other medical devices that include channelsor lumens formed therethrough. System (2) of this example generallyincludes a first station (10) and a second station (12). Stations (10,12) are at least substantially similar in all respects to provide forthe decontamination of two different medical devices simultaneously orin series. First and second decontamination basins (14 a, 14 b) receivethe contaminated devices. Each basin (14 a, 14 b) is selectively sealedby a respective lid (16 a, 16 b). In the present example, lids (16 a, 16b) cooperate with respective basins (14 a, 14 b) to provide amicrobe-blocking relationship to prevent the entrance of environmentalmicrobes into basins (14 a, 14 b) during decontamination operations. Byway of example only, lids (16 a, 16 b) may include a microbe removal orHEPA air filter formed therein for venting.

A control system (20) includes one or more microcontrollers, such as aprogrammable logic controller (PLC), for controlling decontamination anduser interface operations. Although one control system (20) is shownherein as controlling both decontamination stations (10, 12), thoseskilled in the art will recognize that each station (10, 12) can includea dedicated control system. A visual display (22) displaysdecontamination parameters and machine conditions for an operator, andat least one printer (24) prints a hard copy output of thedecontamination parameters for a record to be filed or attached to thedecontaminated device or its storage packaging. It should be understoodthat printer (24) is merely optional. In some versions, visual display(22) is combined with a touch screen input device. In addition, or inthe alternative, a keypad and/or other user input feature is providedfor input of decontamination process parameters and for machine control.Other visual gauges (26) such as pressure meters and the like providedigital or analog output of decontamination or medical device leaktesting data.

FIG. 2 diagrammatically illustrates just one decontamination station(10) of reprocessing system (2), but those skilled in the art willrecognize that decontamination station (12) may be configured andoperable just like decontamination station (10). It should also beunderstood that reprocessing system (2) may be provided with just onesingle decontamination station (10, 12) or more than two decontaminationstations (10, 12).

Decontamination basin (14 a) receives an endoscope (200) (see FIG. 3) orother medical device therein for decontamination. Any internal channelsof endoscope (200) are connected with flush conduits, such as flushlines (30). Each flush line (30) is connected to an outlet of acorresponding pump (32), such that each flush line (30) has a dedicatedpump (32) in this example. Pumps (32) of the present example compriseperistaltic pumps that pump fluid, such as liquid and air, through theflush lines (30) and any internal channels of endoscope (200).Alternatively, any other suitable kind of pump(s) may be used. In thepresent example, pumps (32) can either draw liquid from basin (14 a)through a filtered drain and a valve (S1); or draw decontaminated airfrom an air supply system (36) through a valve (S2). Air supply system(36) of the present example includes a pump (38) and a microbe removalair filter (40) that filters microbes from an incoming air stream.

A pressure switch or sensor (42) is in fluid communication with eachflush line (30) for sensing excessive pressure in the flush line. Anyexcessive pressure or lack of flow sensed may be indicative of a partialor complete blockage (e.g., by bodily tissue or dried bodily fluids) inan endoscope (200) channel to which the relevant flush line (30) isconnected. The isolation of each flush line (30) relative to the otherflush lines (30) allows the particular blocked channel to be easilyidentified and isolated, depending upon which sensor (42) sensesexcessive pressure or lack of flow.

Basin (14 a) is in fluid communication with a water source (50), such asa utility or tap water connection including hot and cold inlets, and amixing valve (52) flowing into a break tank (56). A microbe removalfilter (54), such as a 0.2 μm or smaller absolute pore size filter,decontaminates the incoming water, which is delivered into break tank(56) through the air gap to prevent backflow. A sensor (59) monitorsliquid levels within basin (14 a). An optional water heater (53) can beprovided if an appropriate source of hot water is not available. Thecondition of filter (54) can be monitored by directly monitoring theflow rate of water therethrough or indirectly by monitoring the basinfill time using a float switch or the like. When the flow rate dropsbelow a select threshold, this indicates a partially clogged filterelement that requires replacement.

A basin drain (62) drains liquid from basin (14 a) through an enlargedhelical tube (64) into which elongated portions of endoscope (200) canbe inserted. Drain (62) is in fluid communication with a recirculationpump (70) and a drain pump (72). Recirculation pump (70) recirculatesliquid from basin drain (62) to a spray nozzle assembly (60), whichsprays the liquid into basin (14 a) and onto endoscope (200). A coarsescreen (71) and a fine screen (73) filter out particles in therecirculating fluid. Drain pump (72) pumps liquid from basin drain (62)to a utility drain (74). A level sensor (76) monitors the flow of liquidfrom pump (72) to utility drain (74). Pumps (70, 72) can besimultaneously operated such that liquid is sprayed into basin (14 a)while basin (14 a) is being drained, to encourage the flow of residueout of basin (14 a) and off of endoscope (200). Of course, a single pumpand a valve assembly could replace dual pumps (70, 72).

An inline heater (80) with temperature sensors (82), upstream ofrecirculation pump (70), heats the liquid to optimum temperatures forcleaning and/or disinfection. A pressure switch or sensor (84) measurespressure downstream of circulation pump (70). In some variations, a flowsensor is used instead of pressure sensor (84), to measure fluid flowdownstream of circulation pump (70). Detergent solution (86) is meteredinto the flow downstream of circulation pump (70) via a metering pump(88). A float switch (90) indicates the level of detergent (86)available. Disinfectant (92) is metered into the flow upstream ofcirculation pump (70) via a metering pump (94). To more accurately meterdisinfectant (92), pump (94) fills a metering pre-chamber (96) undercontrol of a fluid level switch (98) and control system (20). By way ofexample only, disinfectant solution (92) may comprise an activatedglutaraldehyde salutation, such as CIDEX® Activated GlutaraldehydeSolution by Advanced Sterilization Products of Irvine, Calif. By way offurther example only, disinfectant solution (92) may compriseortho-phthalaldehyde (OPA), such as CIDEX® ortho-phthalaldeyde solutionby Advanced Sterilization Products of Irvine, Calif. By way of furtherexample only, disinfectant solution (92) may comprise peracetic acid(PAA).

Some endoscopes (200) include a flexible outer housing or sheathsurrounding the individual tubular members and the like that form theinterior channels and other parts of endoscope (200). This housingdefines a closed interior space, which is isolated from patient tissuesand fluids during medical procedures. It may be important that thesheath be maintained intact, without cuts or other holes that wouldallow contamination of the interior space beneath the sheath. Therefore,reprocessing system (2) of the present example includes means fortesting the integrity of such a sheath. In particular, an air pump(e.g., pump (38) or another pump (110)) pressurizes the interior spacedefined by the sheath of endoscope (200) through a conduit (112) and avalve (S5). In the present example, a HEPA or other microbe-removingfilter (113) removes microbes from the pressurizing air. A pressureregulator (114) prevents accidental over pressurization of the sheath.Upon full pressurization, valve (S5) is closed and a pressure sensor(116) looks for a drop in pressure in conduit (112), which wouldindicate the escape of air through the sheath of endoscope (200). Avalve (S6) selectively vents conduit (112) and the sheath of endoscope(200) through an optional filter (118) when the testing procedure iscomplete. An air buffer (120) smoothes out pulsation of pressure fromair pump (110).

In the present example, each station (10, 12) also contains a drip basin(130) and spill sensor (132) to alert the operator to potential leaks.

An alcohol supply (134), controlled by a valve (S3), can supply alcoholto channel pumps (32) after rinsing steps, to assist in removing waterfrom channels (210, 212, 213, 214, 217, 218) of endoscope (200).

Flow rates in lines (30) can be monitored via channel pumps (32) andpressure sensors (42). If one of pressure sensors (42) detects too higha pressure, the associated pump (32) is deactivated. The flow rate ofpump (32) and its activated duration time provide a reasonableindication of the flow rate in an associated line (30). These flow ratesare monitored during the process to check for blockages in any of thechannels of endoscope (200). Alternatively, the decay in the pressurefrom the time pump (32) cycles off can also be used to estimate the flowrate, with faster decay rates being associated with higher flow rates.

A more accurate measurement of flow rate in an individual channel may bedesirable to detect subtler blockages. To that end, a metering tube(136) having a plurality of level indicating sensors (138) fluidlyconnects to the inputs of channel pumps (32). In some versions, areference connection is provided at a low point in metering tube (136)and a plurality of sensors (138) are arranged vertically above thereference connection. By passing a current from the reference pointthrough the fluid to sensors (138), it can be determined which sensors(138) are immersed and therefore determine the level within meteringtube (136). In addition, or in the alternative, any other suitablecomponents and techniques may be used to sense fluid levels. By shuttingvalve (S1) and opening a vent valve (S7), channel pumps (32) drawexclusively from metering tube (136). The amount of fluid being drawncan be very accurately determined based upon sensors (138). By runningeach channel pump (32) in isolation, the flow therethrough can beaccurately determined based upon the time and the volume of fluidemptied from metering tube (136).

In addition to the input and output devices described above, all of theelectrical and electromechanical devices shown are operatively connectedto and controlled by control system (20). Specifically, and withoutlimitation, switches and sensors (42, 59, 76, 84, 90, 98, 114, 116, 132136) provide input (I) to microcontroller (28), which controls thecleaning and/or disinfection cycles and other machine operations inaccordance therewith. For example, microcontroller (28) includes outputs(O) that are operatively connected to pumps (32, 38, 70, 72, 88, 94,100, 110), valves (S1, S2, S3, S5, S6, S7), and heater (80) to controlthese devices for effective cleaning and/or disinfection cycles andother operations.

As shown in FIG. 3, endoscope (200) has a head part (202). Head part(202) includes openings (204, 206) formed therein. During normal use ofendoscope (200), an air/water valve (not shown) and a suction valve (notshown) are arranged in openings (204, 206). A flexible shaft (208) isattached to head part (202). A combined air/water channel (210) and acombined suction/biopsy channel (212) are accommodated in shaft (208). Aseparate air channel (213) and water channel (214) are also arranged inhead part (202) and merge into air/water channel (210) at the locationof a joining point (216). It will be appreciated that the term “joiningpoint” as used herein refers to an intersecting junction rather thanbeing limited to a geometrical point and, the terms may be usedinterchangeably. Furthermore, a separate suction channel (217) andbiopsy channel (218) are accommodated in head part (202) and merge intosuction/biopsy channel (212) at the location of a joining point (220).

In head part (202), air channel (213) and water channel (214) open intoopening (204) for the air/water valve (not shown). Suction channel (217)opens into opening (206) for the suction valve (not shown). Furthermore,a flexible feed hose (222) connects to head part (202) and accommodateschannels (213′, 214′, 217′), which are connected to air channel (213),water channel (214), and suction channel (217) via respective openings(204, 206). In practice, feed hose (222) may also be referred to as thelight-conductor casing. The mutually connecting air channels (213, 213′)will collectively be referred to below as air channel (213). Themutually connecting water channels (214, 214′) will collectively bereferred to below as water channel (214). The mutually connectingsuction channels (217, 217′) will collectively be referred to below assuction channel (217). A connection (226) for air channel (213),connections (228, 228 a) for water channel (214), and a connection (230)for suction channel (217) are arranged on the end section (224) (alsoreferred to as the light conductor connector) of flexible hose (222).When the connection (226) is in use, connection (228 a) is closed off. Aconnection (232) for biopsy channel (218) is arranged on head part(202).

A channel separator (240) is shown inserted into openings (204, 206).Channel separator (240) comprises a body (242) and plug members (244,246), which occlude respective openings (204, 206). A coaxial insert(248) on plug member (244) extends inwardly of opening (204) andterminates in an annular flange (250), which occludes a portion ofopening (204) to separate channel (213) from channel (214). Byconnecting lines (30) to openings (226, 228, 228 a, 230, 232), liquidfor cleaning and disinfection can be flowed through endoscope channels(213, 214, 217, 218) and out of a distal tip (252) of endoscope (200)via channels (210, 212). Channel separator (240) ensures that suchliquid flows all the way through endoscope (200) without leaking out ofopenings (204, 206); and isolates channels (213, 214) from each other sothat each channel (213, 214) has its own independent flow path. One ofskill in the art will appreciate that various endoscopes havingdiffering arrangements of channels and openings may requiremodifications to channel separator (240) to accommodate such differenceswhile occluding ports in head (202) and keeping channels separated fromeach other so that each channel can be flushed independently of theother channels. Otherwise, a blockage in one channel might merelyredirect flow to a connected unblocked channel.

A leakage port (254) on end section (224) leads into an interior portion(256) of endoscope (200) and is used to check for the physical integritythereof, namely to ensure that no leakage has formed between any of thechannels and the interior (256) or from the exterior to the interior(256).

II. Exemplary Medical Device Reprocessing Method with Single-UseDisinfectant

In an exemplary use of reprocessing system (2), an operator may start byactuating a foot pedal (not shown) to open basin lid (16 a). Each lid(16 a, 16 b) may have its own foot pedal. In some versions, oncepressure is removed from the foot pedal, the motion of lid (16 a, 16 b)stops. With lid (16 a) open, the operator inserts shaft (208) ofendoscope (200) into helical circulation tube (64). End section (224)and head section (202) of endoscope (200) are situated within basin (14a), with feed hose (222) coiled within basin (14 a) with as wide adiameter as possible. Next, flush lines (30) are attached to respectiveendoscope openings (226, 228, 228 a, 230, 232). Air line (112) is alsoconnected to connector (254). In some versions, flush lines (30) arecolor coded, and guide located on station (10) provides a reference forthe color-coded connections.

Depending on the customer-selectable configuration, control system (20)may prompt the operator to enter a user code, patient ID, endoscopecode, and/or specialist code. This information may be entered manually(e.g., through touch screen (22)), automatically (e.g., by using anattached barcode wand), or in any other suitable fashion. With theinformation entered (if required), the operator may then close lid (16a). In some versions, closing lid (16 a) requires the operator to pressa hardware button and a touch-screen (22) button simultaneously toprovide a fail-safe mechanism for preventing the operator's hands frombeing caught or pinched by the closing basin lid (16 a). If either thehardware button or software button is released while lid (16 a) is inthe process of closing, the motion of lid (16 a) stops.

Once lid (16 a) is closed, the operator presses a button on touch-screen(22) to begin the washing/disinfection process. At the start of thewashing/disinfection process, air pump (38) is activated and pressurewithin the body of endoscope (200) is monitored. When pressure reaches apredetermined level (e.g., 250 mbar), pump (38) is deactivated, and thepressure is allowed to stabilize for a certain stabilization period(e.g., 6 seconds). If pressure has not reached a certain pressure (e.g.,250 mbar) in a certain time period (e.g., 45 seconds), the program isstopped and the operator is notified of a leak. If pressure drops belowa threshold (e.g., less than 100 mbar) during the stabilization period,the program is stopped and the operator is notified of the condition.Once the pressure has stabilized, the pressure drop is monitored overthe course of a certain duration (e.g., 60 seconds). If the pressuredrop is faster than a predetermined rate (e.g., more than 10 mbar within60 seconds), the program is stopped and the operator is notified of thecondition. If the pressure drop is slower than a predetermined rate(e.g., less than 10 mbar in 60 seconds), reprocessing system (2)continues with the next step. A slight positive pressure is held withinthe body of endoscope (200) during the rest of the process to preventfluids from leaking in.

A second leak test checks the adequacy of connection to the variousports (226, 228, 228 a, 230, 232) and the proper placement of channelseparator (240). A quantity of water is admitted to basin (14 a) so asto submerge the distal end of endoscope (200) in helical tube (64).Valve (S1) is closed and valve (S7) opened; and pumps (32) are run inreverse to draw a vacuum and to ultimately draw liquid into endoscopechannels (210, 212). Pressure sensors (42) are monitored to make surethat the pressure in any one channel (210, 212) does not drop and/orraise by more than a predetermined amount in a given time frame. If itdoes, it likely indicates that one of the connections was not madecorrectly and air is leaking into channel (210, 212). In any event, inthe presence of an unacceptable pressure drop, control system (20) willcancel the cycle and indicate a likely faulty connection, preferablywith an indication of which channel (210, 212) failed.

In the event that the leak tests are passed, reprocessing system (2)continues with a pre-rinse cycle. The purpose of this step is to flushwater through channels (210, 212, 213, 214, 217, 218) to remove wastematerial prior to washing and disinfecting endoscope (200). To initiatethe pre-rinse cycle, basin (14 a) is filled with filtered water and thewater level is detected by pressure sensor (59) below basin (14 a). Thewater is pumped via pumps (32) through the interior of channels (210,212, 213, 214, 217, 218), directly to drain (74). This water is notrecirculated around the exterior surfaces of endoscope 200 during thisstage. As the water is being pumped through channels (210, 212, 213,214, 217, 218), drain pump (72) is activated to ensure that basin (14 a)is also emptied. Drain pump (72) will be turned off when drain switch(76) detects that the drain process is complete. During the drainingprocess, sterile air is blown via air pump (38) through all endoscopechannels (210, 212, 213, 214, 217, 218) simultaneously, to minimizepotential carryover.

Once the pre-rinse cycle is complete, reprocessing system (2) continueswith a wash cycle. To begin the wash cycle, basin (14 a) is filled withwarm water (e.g., approximately 35° C.). Water temperature is controlledby controlling the mix of heated and unheated water. The water level isdetected by pressure sensor (59). Reprocessing system (2) then addsenzymatic detergent to the water circulating in reprocessing system (2)by means of peristaltic metering pump (88). The volume is controlled bycontrolling the delivery time, pump speed, and inner diameter of thetubing of pump (88). Detergent solution (86) is actively pumpedthroughout the internal endoscope channels (210, 212, 213, 214, 217,218) and over the outer surface of endoscope (200) for a predeterminedtime period (e.g., from one to five minutes, or more particularly aboutthree minutes), by channel pumps (32) and external circulation pump(70). Inline heater (80) keeps the temperature at a predeterminedtemperature (e.g., approximately about 35° C.).

After detergent solution (86) has been circulating for a certain periodof time (e.g., a couple of minutes), the flow rate through channels(210, 212, 213, 214, 217, 218) is measured. If the flow rate through anychannel (210, 212, 213, 214, 217, 218) is less than a predetermined ratefor that channel (210, 212, 213, 214, 217, 218), the channel (210, 212,213, 214, 217, 218) is identified as blocked, the program is stopped,and the operator is notified of the condition. Peristaltic pumps (32)are run at their predetermined flow rates and cycle off in the presenceof unacceptably high pressure readings at the associated pressure sensor(42). If a channel (210, 212, 213, 214, 217, 218) is blocked, thepredetermined flow rate will trigger pressure sensor (42), indicatingthe inability to adequately pass this flow rate. As pumps (32) areperistaltic in the present example, their operating flow rate combinedwith the percentage of time they are cycled off due to pressure willprovide the actual flow rate. The flow rate can also be estimated basedupon the decay of the pressure from the time pump (32) cycles off.

At the end of the wash cycle, drain pump (72) is activated to removedetergent solution (86) from basin (14 a) and channels (210, 212, 213,214, 217, 218). Drain pump (72) turns off when drain level sensor (76)indicates that drainage is complete. During the drain process, sterileair is blown through all channels (210, 212, 213, 214, 217, 218) ofendoscope (200) simultaneously to minimize potential carryover.

After the wash cycle is complete, reprocessing system (2) begins a rinsecycle. To initiate this rinse cycle, basin (14 a) is again filled withwarm water (e.g., at approximately 35° C.). Water temperature iscontrolled by controlling the mix of heated and unheated water. Thewater level is detected by pressure sensor (59). The rinse water iscirculated within channels (210, 212, 213, 214, 217, 218) of endoscope(200) via channel pumps (32); and over the exterior of endoscope (200)via circulation pump (70) and sprinkler arm (60) for a certain period oftime (e.g., one minute). As rinse water is pumped through channels (210,212, 213, 214, 217, 218), the flow rate through channels (210, 212, 213,214, 217, 218) is measured and if it falls below the predetermined ratefor any given channel (210, 212, 213, 214, 217, 218), that channel (210,212, 213, 214, 217, 218) is identified as blocked, the program isstopped, and the operator is notified of the condition.

At the end of the rinse cycle, drain pump (72) is activated to removethe rinse water from basin (14 a) and channels (210, 212, 213, 214, 217,218). Drain pump (72) turns off when drain level sensor (76) indicatesthat drainage is complete. During the drain process, sterile air isblown through all channels (210, 212, 213, 214, 217, 218) of endoscope(200) simultaneously to minimize potential carryover. In some versions,the above-described rinsing and draining cycles are repeated at leastonce again, to ensure maximum rinsing of detergent solution (86) fromthe surfaces of endoscope (200) and basin (14 a).

After reprocessing system (2) has completed the desired number ofrinsing and drying cycles, reprocessing system (2) proceeds to adisinfection cycle. To initiate the disinfection cycle, basin (14 a) isfilled with very warm water (e.g., at approximately 53° C.). Watertemperature is controlled by controlling the mix of heated and unheatedwater. The water level is detected by pressure sensor (59). During thefilling process, channel pumps (32) are off in order to ensure that thedisinfectant solution (92) in basin (14 a) is at the in-useconcentration prior to circulating through channels (210, 212, 213, 214,217, 218) of endoscope (200).

Next, a measured volume of disinfectant solution (92) is drawn fromdisinfectant metering pre-chamber (96) and delivered into the water inbasin (14 a) via metering pump (100). The volume of disinfectantsolution (92) is controlled by the positioning of fill level switch (98)relative to the bottom of metering pre-chamber (96). Meteringpre-chamber (96) is filled until fill level switch (98) detects liquid.Disinfectant solution (92) is drawn from metering pre-chamber (96) untilthe level of disinfectant solution (92) in metering pre-chamber (96) isjust below the tip of metering pre-chamber (96). After the necessaryvolume is dispensed, metering pre-chamber (96) is refilled from thebottle of disinfectant solution (92). Disinfectant solution (92) is notadded until basin (14 a) is filled, so that in case of a water supplyproblem, concentrated disinfectant is not left on endoscope (200) withno water to rinse it. While disinfectant solution (92) is being added,channel pumps (32) are off in order to ensure that disinfectant solution(92) in basin (14 a) is at the desired in-use concentration prior tocirculating through channels (210, 212, 213, 214, 217, 218) of endoscope(200).

The in-use disinfectant solution (92) is actively pumped throughoutinternal channels (210, 212, 213, 214, 217, 218) by pumps (32) and overthe outer surface of endoscope (200) by circulation pump (70). This maybe done for any suitable duration (e.g., at least 5 minutes). Thetemperature of the disinfectant solution (92) may be controlled byin-line heater (80) to stay at a consistent temperature (e.g., about52.5° C.). During the disinfection process, flow through each channel(210, 212, 213, 214, 217, 218) of endoscope (200) is verified by timingthe delivery of a measured quantity of solution through channel (210,212, 213, 214, 217, 218). Valve (S1) is closed, and valve (S7) opened,and in turn each channel pump (32) delivers a predetermined volume toits associated channel (210, 212, 213, 214, 217, 218) from metering tube(136). This volume and the time it takes to deliver the volume, providesa very accurate flow rate through the channel (210, 212, 213, 214, 217,218). Anomalies in the flow rate from what is expected for a channel(210, 212, 213, 214, 217, 218) of that diameter and length are flaggedby control system (20) and the process stopped. As in-use disinfectantsolution (92) is pumped through channels (210, 212, 213, 214, 217, 218),the flow rate through channels (210, 212, 213, 214, 217, 218) is alsomeasured as described above.

At the end of the disinfection cycle, drain pump (72) is activated toremove disinfectant solution (92) solution from basin (14 a) andchannels (210, 212, 213, 214, 217, 218). During the draining process,sterile air is blown through all channels (210, 212, 213, 214, 217, 218)of endoscope (200) simultaneously to minimize potential carryover.

After disinfectant solution (92) has been drained from basin (14 a),reprocessing system (2) begins a final rinse cycle. To initiate thiscycle, basin (14 a) is filled with sterile warm water (e.g., atapproximately 45° C.) that has been passed through a filter (e.g., a 0.2μm filter). The rinse water is circulated within channels (210, 212,213, 214, 217, 218) by pumps (32); and over the exterior of endoscope(200) via circulation pump (70) and sprinkler arm 60) for a suitableduration (e.g., 1 minute). As rinse water is pumped through channels(210, 212, 213, 214, 217, 218), the flow rate through channels (210,212, 213, 214, 217, 218) is measured as described above. Drain pump (72)is activated to remove the rinse water from basin (14 a) and channels(210, 212, 213, 214, 217, 218). During the draining process, sterile airis blown through all channels (210, 212, 213, 214, 217, 218) ofendoscope (200) simultaneously to minimize potential carryover. In someversions, the above-described rinsing and draining cycles are repeatedat least two more times, to ensure maximum rinsing of disinfectantsolution (92) residuals from the surfaces of endoscope (200) and basin(14 a).

After the final rinse cycle is complete, reprocessing system (2) beginsa final leak test. In particular, reprocessing system (2) pressurizesthe body of endoscope (200) and measures the leak rate as describedabove. If the final leak test is successful, reprocessing system (2)indicates the successful completion of the cycles via touch-screen (22).From the time of program completion to the time at which lid (16 a) isopened, pressure within the body of endoscope (200) is normalized toatmospheric pressure by opening vent valve (S5) at a predetermined rate(e.g., valve (S5) opened for 10 seconds every minute).

Depending on customer-selected configuration, reprocessing system (2)may prevent lid (16 a) from being opened until a valid useridentification code is entered. Information about the completed program,including the user ID, endoscope ID, specialist ID, and patient ID arestored along with the sensor data obtained throughout the program. If aprinter is connected to reprocessing system (2), and if requested by theoperator, a record of the disinfection program will be printed. Once avalid user identification code has been entered, lid (16 a) may beopened (e.g., using the foot pedal as described above). Endoscope (200)is then disconnected from flush lines (30) and removed from basin (14a). Lid (16 a) can then be closed using both the hardware and softwarebuttons as described above.

III. Exemplary Medical Device Reprocessing with Reusable Disinfectant

In some instances, it may be desirable to collect and reuse disinfectantone or more times rather than drain and dispose of the disinfectantafter a single use. For example, reusing disinfectant uses less totaldisinfectant over the useful life of reprocessing system (2) and maythus decrease the overall cost of operation. In addition, concentrateddisinfectant, such as the disinfectant provided from disinfectantstorage (92), may have a damaging effect on one or more portions ofreprocessing system (2) until mixed with water as a disinfectantsolution in the desired concentrations. Storing and reusing thedisinfectant solution thus reduces the presence of concentrateddisinfectant and may thus increase the useful life of reprocessingsystem (2).

FIG. 4 shows an exemplary reprocessing system (310) that has adisinfectant storage reservoir (360) from which to pump the disinfectantto basin (14 a) and collect the disinfectant after completion of thedisinfection cycle. Alternative versions of reprocessing system (410,510, 610) discussed herein also include exemplary disinfection storagereservoir (360). It will be appreciated that various aspects of reusingdisinfectant may be used with respect to any of reprocessing systems (2,310, 410, 510, 610) and in any combination as described herein.

As shown in FIG. 4, reprocessing system (310), with second exemplaryreprocessing system (310) includes a primary pump (312) that receivesthe fluid, such as the water and/or disinfectant, and pumps the fluidtoward the collection of valves (336, 338, 340, 342, 344) as discussedabove with respect to various cycles. More particularly, disinfectionvalve (340) is configured to transition between a circulation state anda collection state during the disinfection cycle. With disinfectionvalve (340) in the circulation state, the collection of valves (336,338, 340, 342, 344) is configured to return disinfectant toward flushlines (30) and nozzle assembly (322) for continued circulation duringreprocessing. At the conclusion of the disinfection cycle, disinfectionvalve (340) transitions from the circulation state to the collectionstate and, in conjunction with the remaining collection of valves (336,338, 342, 344), directs the disinfectant into disinfectant storagereservoir (360) for reuse in future disinfection cycles. As used herein,the term “disinfectant” refers to concentrated disinfectant or anysolution including disinfectant at any concentration. The term“disinfectant” is thus not intended to unnecessarily limit the inventionto a particular concentration or solution of disinfectant.

Reprocessing system (310) further includes disinfectant pump (94) influid communication between disinfectant storage reservoir (360) andbasin (14 a). Disinfectant pump (94) thus pumps the disinfectantdirectly into basin (14 a). Check valve (330) is also fluidly connectedbetween basin (14 a) and disinfectant pump (94) and is configured toinhibit fluid within basin (14 a) from flowing backward toward pump(94). In some versions, disinfectant storage reservoir (360) is in theform of a break tank such that primary pump (312) and disinfectant pump(94) are configured to individually and/or simultaneously interact withdisinfectant storage reservoir (360). However, it will be appreciatedthat alternative couplings and other features may be used to fluidlycouple any form of disinfectant storage reservoir (360) withinreprocessing system (310) for collecting and reusing disinfectant. Theinvention is thus not intended to be limited to the particulardisinfectant storage reservoir (360).

Reprocessing system (310) of this example may be readily incorporatedinto stations (10, 12) (see FIG. 1) with basins (14 a, 14 b). Basin (14a) shown in FIG. 4 thus receives water from water source (50) anddischarges all water therefrom via drain (74), as discussed above.Exemplary basin (14 a) includes a plurality of flush lines (30)extending therein and a nozzle assembly (322) having a plurality ofnozzles (324). Each flush line (30) and nozzle (324) is configured todirect the water and/or any additive solution, which may be generallyreferred to as the fluid, toward endoscope (200) (see FIG. 3) withinbasin (14 a) for reprocessing. As discussed above, flush lines (30) areconfigured to discharge the fluid into respective channels (210, 212,217, 218) (see FIG. 3), at respective predetermined conduit flow ratesparticularly configured for each respective channel (210, 212, 217, 218)(see FIG. 3). To this end, primary pump (312) pumps a predeterminedsupply flow rate of the fluid collectively to flush lines (30) via acommon manifold (326) that is fluidly coupled therebetween.

A plurality of flush valves (314, 316, 318, 320) are positionedrespectively in each flush line (30) and are collectively configured tobalance fluid flow from primary pump (312) such that each flush line(30) discharges fluid therefrom at respective predetermined conduit flowrates. In some versions, flush lines (30) deliver four differentrespective predetermined conduit flow rates of fluid to channels (210,212, 217, 218) (see FIG. 3). In some other versions, one or more of therespective predetermined conduit flow rates are approximately equivalentto accommodate an alternative medical device. In any case, any number offlush lines (30) configured to deliver fluid at any predeterminedconduit flow rates may be used to accommodate one or more types ofmedical devices.

Water source (50) delivers the water to a three-way introduction valve(328), which directs the water through filter (54), check valve (330),and two-way valve (332) into basin (14 a). As in reprocessing system (2)(see FIG. 2), the water may be collected to a desirable amount asdetected by level sensors (59 a, 59 b, 76). The water drains from basin(14 a) and may pass through heater (80) and two-way valve (334) to reachprimary pump (312) for distribution toward flush lines (30) and nozzleassembly (322). More particularly a collection of two-way valves (336,338, 340, 342, 344) are fluidly connected downstream of primary pump(312) to either allow or inhibit fluid flow therethrough for variouscycles as discussed herein. For example, flush valve (336) and nozzlevalve (338) are configured to control flow respectively toward flushlines (30) and nozzle assembly (322).

In addition, disinfectant valve (340), drain valve (342), and returnvalve (344) are respectively configured to provide disinfection ofendoscope (200), drainage from reprocessing system (310), andself-disinfection of reprocessing system (310). Disinfection andself-disinfection will be discussed below in additional detail. In thepresent example, disinfection valve (340), drain valve (342), and returnvalve (344) are presumed fully closed so as to direct the entirety ofthe predetermined supply flow of the fluid through the opened flush andnozzle valves (336, 338). However, the collection of valves (336, 338,340, 342, 344) may be fully opened, partially opened, and/or fullyclosed so as to direct the fluid in any one of a plurality of desirableratios to complete the cycles of reprocessing. The invention is thus notintended to be limited specifically to the combination of open and/orclosed valves as described herein.

Downstream of flush valve (336), additive storages, such as detergentand alcohol storage (86, 134), and detergent metering pump (88), analcohol metering pump (346), and a gas pump (38) fluidly connect to bereceived with or in place of water flowing toward flush lines (30). Aseries of optional two-way valves (348) may be fluidly connecteddownstream of pumps (88, 346, 38) for additional flow control of variousadditives. In any case, the fluid, such as water, is received withinmanifold (326) at the predetermined supply flow rate. As shown inexemplary reprocessing system (310) of FIG. 4, each of the four flushlines (30) fluidly connects to manifold (326) and extends into basin (14a) for connection with channels (210, 212, 217, 218) (see FIG. 3) ofendoscope (200). More particularly, each flush line (30) includes acoupling port (350) within basin (14 a) that is configured to fluidlyseal against endoscope (200) for fluidly coupling channels (210, 212,217, 218) (see FIG. 3) with respective flush lines (30).

As briefly discussed above, each flush line (30) includes its respectiveflush valve (314, 316, 318, 320) configured to balance fluid flows alongflush lines (30) according to the predetermined conduit flow rates. Insome versions, flush valves (314, 316, 318, 320) are in the form oforifice valves that are sized relative to each to each other to createpredetermined restriction on the fluid entering manifold (326) accordingto the predetermined supply flow rate. As the pressure within themanifold (326) distributes equally through flush lines (30),predetermined conduit flow rates of fluid flow through each respectiveflush valve (314, 316, 318, 320) and discharge from coupling ports(350). Alternatively, flush valves (314, 316, 318, 320) may eachcomprise a variable valve configured to provide a discrete,predetermined flow rate so that the operator may adjust various flowrates to accommodate differing medical devices in reprocessing system(310).

Furthermore, nozzle valve (338) also receives the fluid, such as water,from primary pump (312) and directs the fluid toward nozzle assembly(322). Each nozzle (324) is generally identical in the present exampleand configured to discharge fluid onto the exterior of endoscope (200)(see FIG. 3) within basin (14 a) at approximately equivalentpredetermined nozzle flow rates. To this end, nozzle valve (338) isconfigured to further balance the predetermined supply flow rate offluid with flush valves (314, 316, 318, 320) such that each nozzle (324)and fluid line (30) discharges fluid therefrom according to itspredetermined conduit flow rate and predetermined nozzle flow rate,respectively. Similar to flush valves (314, 316, 318, 320), nozzle valve(338) may also be a variable valve configured to set to a discrete,predetermined flow rate so that the operator may adjust various flowrates to accommodate differing medical devices in reprocessing system(310). Alternatively, nozzle valve (338) in an open position may providenegligible resistance such that the various predetermined flow rates arebalanced simply by restriction in each respective nozzle (324).

In use, reprocessing system (310) receives water from water supply (50)into basin (14 a). Alternatively, basin (14 a) may receive one of theadditives alone or in combination with the water. In any case, the fluidcollected within basin (14 a) is received within primary pump (312) andpumped therefrom at the predetermined supply flow rate. The collectionof valves (338, 340, 342, 344) are generally configured to direct thefluid at the predetermined supply flow rate toward manifold (326) andnozzle assembly (322). The fluid flowing toward manifold (326) may alsoreceive one of the additives, such as detergent, as discussed above inadditional detail.

A predetermined portion of the fluid flows into manifold (326), while aremaining predetermined portion of the fluid flows through nozzle valve(338). Flush valves (336) and nozzle valve (338) generate predeterminedrestriction in each respective flush line (30) in order to direct fluidflow along each flush line (30) with at least two different respectivepredetermined conduit flow rates. Such predetermined restriction andrestriction results in flush valves (336) and nozzle valve (338)apportioning the fluid flow therethrough according to the variouspredetermined flow rates. For example, flush valves (336) and nozzlevalve (338) may be configured to direct fluid along four flush lines(30) with four different respective predetermined conduit flow rates.Once balanced accordingly, the fluid discharges from each coupling port(350) and into respective channels (210, 212, 217, 218) (see FIG. 3)with the predetermined conduit flow rates for reprocessing endoscope(200) (see FIG. 3). It will be appreciated that generating suchpredetermined flow rates via valves (336, 338) may be used in any cycleof reprocessing described herein and is not intended to limit theinvention to any specific reprocessing cycle.

Reprocessing system (310) of the present example includes only oneprimary pump (312) supplying the predetermined supply flow rate of fluidto each flush line (30) and nozzle (324). However, it will beappreciated that any number of pumps may be used in combination, such asin series or parallel, to direct fluid as discussed above. It willtherefore be appreciated that the invention is not intended tounnecessarily be limited to only one primary pump (312). By way offurther example only, reprocessing system (310) may be configured andoperable in accordance with at least some of the teachings of U.S.patent application Ser. No. 15/157,800, entitled “Apparatus and Methodfor Reprocessing a Medical Device,” filed on May 18, 2016, thedisclosure of which is incorporated by reference herein.

FIG. 5 shows another exemplary reprocessing system (310′), which hasanother exemplary disinfectant storage reservoir (360′) fluidlyconnected between disinfectant valve (340) and pump (94). Disinfectantstorage reservoir (360′) is generally similar to disinfectant storagereservoir (360) (see FIG. 4), but also includes additional features forfurther preparing and maintaining the disinfectant for reprocessing.Specifically, disinfectant storage reservoir (360′) includes adisinfectant heater (361′) that is configured to heat the disinfectantfor reprocessing. In some versions, disinfectant heater (361′) isconfigured to pre-heat the disinfectant in anticipation of use in orderto more quickly heat the fluid circulating through reprocessing system(310′) for reasons discussed below in additional detail. Alternativelyor in addition, disinfectant heater (361′) may heat the disinfectantwhile flowing from disinfectant storage reservoir (360′) toward pump(94) for use. In either case, disinfectant heater (361′) may beconfigured to heat the fluid in conjunction with heater (80) forcollectively heating the fluid as it flows through reprocessing system(310′).

Disinfectant storage reservoir (360′) further includes a maximum levelsensor (362′), a minimum level sensor (363′), and a temperature sensor(364′) for monitoring the disinfectant flowing through and/or containedwithin disinfectant storage reservoir (360′). Maximum and minimum levelsensors (362′, 363′) are configured to approximate the amount ofdisinfectant contained within disinfectant storage reservoir (360′) andcommunicate with another system, such as control system (20) (see FIG.1). For example, maximum and minimum level sensors (362′, 363′) andcontrol system (20) (see FIG. 1) collectively monitor the amount ofdisinfectant to be above the maximum level, below the minimum level, orbetween the maximum and minimum levels, which is generally desired foroperation. Temperature sensor (364′) also communicates with anothersystem, such as control system (20) (see FIG. 1), to monitor thetemperature of the disinfectant.

In order to further monitor the disinfectant, reprocessing system (310′)also includes a disinfectant concentration measuring subsystem (365′)that is configured to receive the disinfectant from at least onelocation within reprocessing system (310′) for sampling and testing. Tothis end, disinfectant concentration measuring subsystem (365′) of thepresent example receives the disinfectant samples from filter (54) andfrom at least one of flush lines (30). Disinfectant concentrationmeasuring subsystem (365′) is configured to test samples of disinfectantreceived from filter (54) and flush line (30) for a concentration ofdisinfectant present within the fluid flowing therethrough. In the eventthat the measured concentration of disinfectant is not within apredetermined range of concentration or is below a predetermined minimumconcentration, disinfectant concentration measuring subsystem (365′)notifies the operator accordingly. Such measurement and notification maybe further aided by communication with control system (20) (see FIG. 1)discussed above in greater detail.

Upon completion of sampling and testing, the disinfectant drains todrain sump (130) such that disinfectant concentration measuringsubsystem (365′) is available for further use. In parallel, filter (54)also drains directly to drain sump (130) in the event that fluid is notdirected toward disinfectant concentration measuring subsystem (365′).It will be appreciated that various devices and method for measuringdisinfectant concentration and notifying the operator may be used asdescribed herein and, as such, the invention is not intended to beunnecessarily limited to any particular disinfectant concentrationmeasuring subsystem. By way of further example only, disinfectantconcentration measuring subsystem (365′) may be configured and operablein accordance with at least some of the teachings of U.S. patentapplication Ser. No. 15/157,952, entitled “Apparatus and Method toMeasure Concentration of Disinfectant in Medical Device ReprocessingSystem,” filed on May 18, 2016, the disclosure of which is incorporatedby reference herein.

Additional monitoring is provided in reprocessing system (310′) by abasin temperature sensor (366′), a drain sump overflow sensor (367′),and a plurality of flow sensors (368′). Basin temperature sensor (366′)is generally configured to measure the temperature of fluid therein,while drain sump overflow sensor (367′) is configured to measure anexcess of fluid collected within drain sump (130) for alerting theoperator. Each flow sensor (368′) is configured to measure thevolumetric flow rate of fluid flowing therethrough for monitoring theoverall circulation of fluid through reprocessing system (310′). Each oftemperature sensor (366′), drain sump overflow sensor (367′), and flowsensors (368′) may communicate with control system (20) (see FIG. 1) forcollective operation with any one or more of the sensors discussedherein for using reprocessing system (310). However, it will beappreciated that alternative devices and methods of monitoringreprocessing system (310′) may be used and that the invention describedherein is not intended to be unnecessarily limited to reprocessingsystem (310′).

IV. Exemplary Medical Device Reprocessing Apparatus and Method forRecurring Flow Cycles

In some instances, it may be desirable to increase the bioburdenreduction within an internal channel of an endoscope by directing a flowof various solutions, liquids, and/or pressurized air through theendoscope. Although depositing detergents and/or disinfectants withinthe internal channel of an endoscope may lower the bioburden level ofthe channels, decreasing the bioburden level in internal channels ofendoscopes to a desired level may be particularly difficult due to thesmall diameters and sometimes irregular profiles of the internalchannels. In some cases, simply maintaining a disinfectant or detergentwithin the internal channels of an endoscope for a specified durationmay significantly increase the time required to achieve the desiredlevel of bioburden reduction efficacy. In some instances, an endoscope(200) may include an elevator channel with a cable or wire positionedtherein, such as in a duodenoscope. With the presence of a cable or wirecontained within the elevator channel, an additional restriction iscreated as the volume of disinfectant that can flow through the elevatorchannel is limited. Where the cable is in the form of a twisted cable,numerous gaps and crevices are present that are capable of housingvarious bioburdens and other particles.

Internal channels (210, 212, 213, 214, 217, 218) of endoscopes (200),and elevator channels of duodenoscopes, may be formed of a material thatis more chemical-resistant than the outer surfaces of endoscopes (200).As merely an illustrative example, internal channels (210, 212, 213,214, 217, 218) may be formed of Teflon or metals that have a highertolerance to chemical or heat exposure. Accordingly, internal channels(210, 212, 213, 214, 217, 218) are capable of being exposed to a higherconcentration of disinfectant or detergent and/or a higher temperature.Additionally, due to the narrow configuration, and sometimes irregularprofile, of internal channels (210, 212, 213, 214, 217, 218), utilizinga higher level of concentration may be desirable to effectively achievebioburden reduction within internal channels (210, 212, 213, 214, 217,218) due to the greater difficulty in disinfecting internal channels(210, 212, 213, 214, 217, 218) than the outer surface of endoscope(200).

Reprocessing apparatuses that alternate between directing varyingtreatment solutions through an endoscope (200) may be desirable toincrease the bioburden reduction efficacy of the internal channels (210,212, 213, 214, 217, 218). Providing a recurring cycle where variousliquids, detergents, and disinfectants flow through internal channels(210, 212, 213, 214, 217, 218) of endoscopes (200) may be beneficial tolower the bioburden level within the channel (210, 212, 213, 214, 217,218). As these types of liquids flow reiteratively through internalchannels (210, 212, 213, 214, 217, 218), a shear stress is generated onthe inner walls of internal channels (210, 212, 213, 214, 217, 218)proportional to the flow rate. The inner walls of internal channels(210, 212, 213, 214, 217, 218) are limited to the extent of shear stressthat they can be exposed to before internal channels (210, 212, 213,214, 217, 218) become damaged. Thus, it may be desirable to directpressurized air through internal channels (210, 212, 213, 214, 217, 218)to increase the flow rate of the liquid and displace the liquidcontained therein. The flow rate of the liquid in the channel (210, 212,213, 214, 217, 218) significantly increases as more liquid is displacedwith air. The amount of flow rate is inversely proportional to thelength of channels (210, 212, 213, 214, 217, 218), as demonstrated inthe Hagen-Poiseuille' s equation provided below:

${Q = {\frac{dV}{dt} = {{v\; \pi \; R^{2}} = {{\frac{\pi \; R^{4}}{8n}\left( {- \frac{\Delta \; P}{\Delta \; x}} \right)} = {\frac{\pi \; R^{4}}{8n}\frac{\left| {\Delta \; P} \right|}{L}}}}}};$

where in compatible units (e.g., SI): “Q” is the volumetric flow rate;“V(t)” is the volume of the liquid transferred as a function of time,“t”; “v” is mean fluid velocity along the length of the tube; “x” is thedistance in direction of flow; “R” is the internal radius of the tube;“ΔP” is the pressure difference between the two ends; “n” is the dynamicfluid viscosity; and “L” is the length of the tube.

In this instance, the shear stress of the inner wall is increased andthe amount of bioburden removal is enhanced. The amount of shear stressis proportional to the flow rate, as shown by the following formula:

$\begin{matrix}{{\tau = {\frac{32\mu}{\pi \; D^{3}}Q}};} & (3)\end{matrix}$

where “μ” is the viscosity of water and “Q” is the flow rate.

Repeatedly directing a stream of pressurized air through the internalchannels (210, 212, 213, 214, 217, 218), once a detergent ordisinfectant solution has passed therethrough, may be further desirableto flush the remaining liquid out of endoscope (200) to ensure anyremnants from a prior cycle is substantially removed. By repeatedlyfilling and purging the internal channels (210, 212, 213, 214, 217, 218)of an endoscope (200), the total time required to remove a certain levelof bioburden may be reduced; and in any subsequent cycle introducing ahigh concentration of disinfectant, that disinfectant is less likely tobe diluted by residual fluid in channels (210, 212, 213, 214, 217, 218).The following description provides various examples of a reprocessingsystem that is configured to deliver a reiterative cycle of varioussubstances and solutions to the internal channels of a medicalinstrument. A reprocessing system may include a single pump assemblythat is configured to deliver the various substances, such as detergent,water, pressurized air, etc. In this instance, the reprocessing systemmay be configured to selectively open and close a series of valves toindividually deliver the various substances through the single pumpassembly. Alternatively, as shown below, a reprocessing system mayinclude a separate, dedicated pump to deliver each varying substance tointernal channels (210, 212, 213, 214, 217, 218). Although individualpumps are described below, it should be understood that a single pumpsystem or pump assembly may be utilized to implement the reprocessingmethods detailed below.

A. Medical Device Reprocessing Apparatus and Method Using Pre-DilutedDisinfectant

In some instances, as previously discussed above, it may be desirable toreutilize formerly used disinfectant from a prior cleaning cycle of theinternal channels (210, 212, 213, 214, 217, 218) of an endoscope (200)in a subsequent cycle. A reprocessing method that involves redepositingthe disinfectant within the internal channels (210, 212, 213, 214, 217,218) of an endoscope (200) for future cycles may be beneficial toadequately disinfect the inner components of the endoscope (200) whilereducing the need for additional disinfectant for each subsequent cycle.Reutilizing disinfectant for multiple cleaning cycles may thus minimizecosts while achieving a sufficient level of biocidal activity. Duringeach instance of delivering previously utilized disinfectant intointernal channels (210, 212, 213, 214, 217, 218), the dilution factor ofthe disinfectant may decrease dramatically. The concentration of thedisinfectant in the channel (210, 212, 213, 214, 217, 218) can beestimated using the following formula: C_(n)=C_(i)−(C_(i)×R^(n)), where“C_(n)” is the disinfectant concentration in the channel after “n”number of purge and fill cycles; “C_(i)” is the initial undiluteddisinfectant concentration; and “R” is the remaining percentage of fluidin the channel after purging. The table below shows the channeldisinfectant concentration at different parameters:

Number Remain- Remain- Remain- Remain- Remain- of Purge ing % ing % ing% ing % ing % & Fill 10% 20% 30% 40% 50% 1 90 80 70 60 50 2 99 96 91 8475 3 99.9 99.2 97.3 93.6 87.5

The following description provides various examples of a reprocessingsystem and method configured to adequately decontaminate the internalchannels (210, 212, 213, 214, 217, 218) of an endoscope (200) through arecurring cleaning cycle. Ultimately, providing a methodical approach todisinfecting the inner components of an endoscope (200) may bebeneficial to ensure the proper degree of bioburden reduction isachieved in each instance. It should be understood that the reprocessingmethod described below may be readily incorporated into any of thevarious reprocessing systems (2, 310, 310′) and to any of the variousendoscopes (200) described above. Other suitable ways in which thebelow-described reprocessing method may be used will be apparent tothose of ordinary skill in the art in view of the teachings herein.

FIG. 6 shows a block schematic of an exemplary reprocessing system (410)including a disinfectant storage (411), a detergent storage (415), anair supply system (421), and a water supply (425). Except as otherwisedescribed below, reprocessing system (410), disinfectant storage (411),detergent storage (415), air supply system (421), and water reservoir(425) are configured and operable just like reprocessing system (2, 310,310′), disinfectant storage (92, 360), disinfectant (86), air supplysystem (36), and water supply (50), respectively, described above.Internal channels (420) of an endoscope (400) are in fluid communicationwith disinfectant storage (411), detergent storage (415), air supplysystem (421) and water reservoir (425) via flush lines (444).Reprocessing system (410) is operable to deliver disinfectant solution(92), detergent solution (86), air and water to internal channels (420)of endoscope (400) individually and sequentially. While only oneendoscope (400) is shown as being reprocessed in reprocessing system(410), it should be understood that reprocessing system (410) may becapable of reprocessing more than one endoscope (400) simultaneouslyand/or in a sequence.

Flush lines (444) include a flush valve (446) for each channel (420)operatively connected to reprocessing system (410). Flush valves (446)are positioned downstream of disinfectant storage (411), detergentstorage (415), air supply system (421), and water reservoir (425). Inthe present example, disinfectant storage (411) is in fluidcommunication with a disinfectant pump (412), a flow sensor (413) and acheck valve (414) in sequence, such that disinfectant pump (412) isconfigured to transfer disinfectant (92) from disinfectant storage (411)to flow sensor (413) and through check valve (414) via flush lines(444). In this instance, disinfectant solution (92) is a highconcentrate disinfectant that is capable of providing adequate bioburdenreduction within internal channels (420).

Flow sensor (413) is operable to monitor the flow of concentrateddisinfectant (92) delivered from disinfectant pump (412) to internalchannels (420) of endoscopes (400). Control system (20) of reprocessingsystem (410) is configured to execute a control algorithm (see FIG. 7)to open flush valve (446), which is in fluid connection with endoscope(400), and retrieve the data monitored by flow sensor (413). Controlsystem (20) is operable to terminate fluid communication betweendisinfectant pump (412) and endoscope (400) when the data obtained fromflow sensor (413) indicates that internal channel (420) has received asufficient amount of concentrated disinfectant (92) by closing off flushvalve (446).

Similarly, detergent storage (415) is in fluid communication with adetergent pump (416), a flow sensor (417) and a check valve (418) insequence, such that detergent pump (416) is configured to transferdetergent solution (86) to flow sensor (417) and through check valve(418) via flush lines (444). Flow sensor (417) is operable to monitorthe elapsed duration as detergent (86) is delivered from detergent pump(416) to internal channels (420) of endoscope (400). Reprocessing system(410) is configured to terminate the fluid communication betweendetergent pump (416) and flush valve (446) once the elapsed duration asmonitored by flow sensor (417) has reached a predetermined timethreshold. Alternatively, or in conjunction, reprocessing system (410)is configured to cease operation of detergent pump (416) from pumpingdetergent (86) to internal channels (420). In each instance,reprocessing system (410) is configured to close flush valve (446) wheninternal channel (420) has received a sufficient amount of detergent(86) therein, as sensed by flow sensor (417).

Air supply system (421) is in communication with an air pump (422), afilter (423) and a check valve (424). Air pump (422) is configured topush pressurized air from air supply system (421) through filter (423)and check valve (424), thereby delivering a stream of air into andthrough internal channels (420) of endoscope (400). Filter (423) isoperable to filter and remove microbes from the incoming air streamextracted from air supply system (421). In some illustrative examples,filter (423) comprises a HEPA microbe-removing filter. In some versions,reprocessing system (410) may exclude filter (423) in communication withair pump (422) and check valve (424). Water reservoir (425) is in fluidcommunication with a water pump (426), a flow sensor (427) and a checkvalve (428). Water pump (426) is configured to pump water from waterreservoir (425) to flow sensor (427) and through check valve (428) viaflush lines (444). Reprocessing system (410) is operable to measure thequantity of water delivered from water pump (426) to internal channel(420) of endoscope (400), based on data from flow sensor (427).Reprocessing system (410) is further configured to close flush valve(446) upon determining that internal channel (420) has received asufficient amount of water therein, as sensed by flow sensor (427).

Reprocessing system (410) further includes basin (14 a) in fluidcommunication with internal channels (420) of endoscope (400) via flushlines (444). Basin (14 a) is operable to receive any fluids or airreleased from internal channels (420). Further, basin (14 a) is in fluidcommunication with disinfectant pump (412) via flush line (444) suchthat disinfectant pump (412) is operable to draw the released fluidswithin basin (14 a) to disinfectant pump (412). The released fluid isrecycled through reprocessing system (410) when disinfectant pump (412)reactivates to pump a subsequent amount of disinfectant (92) throughflow sensor (413), check valve (414) and into internal channels (420).For example, with basin (14 a) holding previously used disinfectant (92)recently released from internal channels (420), basin (14 a) is operableto transfer the previously used disinfectant (92) to disinfectant pump(412) for reuse. In this instance, disinfectant pump (412) is configuredto pump the previously used disinfectant (92) into internal channels(420) again. Simultaneously, disinfectant pump (412) is furtherconfigured to obtain a new portion of disinfectant (92) fromdisinfectant storage (411) for mixture and delivery with the previouslyused disinfectant (92) received from basin (14 a).

As seen in FIG. 6, reprocessing system (410) includes a first variablevalve (448) in line between disinfectant storage (411) and disinfectantpump (412) and a second variable valve (450) between basin (14 a) anddisinfectant pump (412). Reprocessing system (410) is operable toselectively open and close variable valves (448, 450) to drawdisinfectant (92) from disinfectant storage (411) and separately, orsimultaneously, pull fluid from basin (14 a), respectively. Forinstance, with first variable valve (448) in an open state and withsecond variable valve (450) in a closed state, operation of disinfectantpump (412) pulls disinfectant (92) from disinfectant storage (411). Withfirst variable valve (448) in a closed state and with second variablevalve (450) in an open state, disinfectant pump (412) is operable todraw fluids from within basin (14 a).

In some versions, reprocessing system (410) is configured to maintainvariable valves (448, 450) simultaneously open. In this instance, unlikeflush valves (446), variable valves (448, 450) include variable orificesthat are configured to be selectively adjusted. Reprocessing system(410) is configured to adjust the size of the orifice of variable valves(448, 450) to thereby selectively control the amount of disinfectant(92) pulled from disinfectant storage (411) and the amount of releasedfluids drawn from basin (14 a) through the operation of disinfectantpump (412). In this instance, reprocessing system (410) is operable tocooperatively manipulate the opening dimensions of variable valves (448,450) to thereby deliver varied doses and/or concentrations ofdisinfectant (92) to internal channels (410) during subsequentdisinfecting cycles. Although not shown, it should be understood thatreprocessing system (410) may include a single pump assembly such thatthe same pump assembly is configured to deliver detergent (86), water,pressurized air, and detergent (92). In this instance, reprocessingsystem (410) is configured to selectively open and close a series offlush valves (446) to individually deliver the various substances withthe single pump assembly.

FIG. 7 shows a flow diagram illustrating steps of an exemplaryreprocessing method (480) that may be used by reprocessing system (410)to perform a predetermined number of fill and purge cycles of internalchannels (420) of endoscope (400). At step (482), reprocessing system(410) initiates detergent pump (412) to deliver detergent solution (86)to endoscope (400) via flush lines (444). Reprocessing system (410) isconfigured to deliver detergent (86) through internal channels (420) ata predetermined flow rate. At step (484), as detergent (86) istransferred from detergent storage (415) to endoscope (400), flow sensor(417) measures an elapsed duration of flow as detergent pump (416)actively pumps detergent (86) toward internal channels (420).Reprocessing system (410) ceases operation of detergent pump (416) whenthe elapsed flow time equals a predetermined time threshold fordetergent delivery. Subsequently, at step (486), reprocessing system(410) initiates water pump (426) to deliver water to endoscope (400) viaflush lines (444) and through internal channels (420), to thereby rinseany remaining detergent (86) out from internal channels (420) and intobasin (14 a). In this instance, flow sensor (427) measures an elapsedduration of flow as water pump (426) actively pumps water towardinternal channels (420). Reprocessing system (410) ceases operation ofwater pump (426) when the elapsed flow time equals a predetermined timethreshold for rinsing.

At step (488), reprocessing system (410) initiates air pump (422) tosend pressurized air from air supply system (421) through filter (423)and into endoscope (400). The stream of air passes through internalchannels (420) thereby purging internal channels (420) of any residualdetergent (86) or water contained therein. Air pump (422) continues toflow pressurized air through internal channels (420) until a specifiedflow duration elapses, signaling for reprocessing system (410) to ceaseoperation of air pump (422). Reprocessing system (410) terminates airpump (422) once the elapsed flow time has reached a predetermined timethreshold for air purging. At step (490), with air pump (422) inactive,disinfectant pump (412) beings to pump high concentrate disinfectant(92) to internal channels (420) of endoscope (400) simultaneously.

Reprocessing system (410) monitors the volume of disinfectant (92)transferred from disinfectant storage (411) to endoscope (400) andceases operation of disinfectant pump (412) when the volume deliveredsubstantially equals a predetermined threshold, as seen at step (492).Reprocessing system (410) closes all flush valves (446) simultaneouswith the deactivation of disinfectant pump (412). In this instance, asseen at step (494), reprocessing system (410) evaluates whether internalchannels (420) of endoscope (400) have stored the high concentratedisinfectant (92) for a minimum dwell time. As merely an illustrativeexample, the predetermined dwell time can range between approximately 10seconds to 30 seconds. Although not shown, it should be understood thatin some versions reprocessing system (410) may forego holding the highconcentrate disinfectant (92) in the internal channels (420) for theminimum dwell time. Instead, flush valves (446) may remain open afterthe deactivation of disinfectant pump (412) and reprocessing system(410) may initiate water pump (526) and air pump (422), respectively insequential order as described above.

At step (496), once reprocessing system (410) has determined thatinternal channels (420) have maintained disinfectant (92) for theminimum dwell time, flush valves (446) are reopened and air pump (422)is reactivated. In this instance, pressurized air is flowed throughinternal channels (420) to thereby purge disinfectant (92) fromendoscope (400). The flow rate of disinfectant (92) being released fromwithin internal channels (420) into basin (14 a) is increased due to theflow of pressurized air, thereby enhancing the bioburden removal. Atstep (497), with disinfectant (92) released into basin (14 a) andcontained therein, reprocessing system (410) determines whether theabove described fill and purge process has been performed apredetermined “n” number of times. By way of example only, thepredetermined “n” number of times may be two times, three times, fourtimes, five times, six times, or more times. Upon the determination byreprocessing system (410) that additional fill and purge cycles remainto be completed, reprocessing system (410) transfers the previously useddisinfectant (92) from basin (14 a) to disinfectant pump (412) forsubsequent use in the next cycle, as seen in step (498).

In this instance, reprocessing system (410) will continue to performstep (490) through step (497) until reprocessing system (410) determinesthat no additional fill and purge cycles remain to be completed. Inother words, reprocessing method (480) will proceed to step (499) whenreprocessing system (410) has performed reprocessing method (480) thepredetermined “n” number of times. At step (499), reprocessing system(410) ceases continuation of reprocessing method (480).

B. Medical Device Reprocessing Apparatus and Method Using ConcentratedDisinfectant

As previously mentioned, in some instances an endoscope (200) mayinclude an elevator channel with a cable or wire positioned therein,such as in a duodenoscope. The cable contained within an elevatorchannel of a duodenoscope may be in the form of a twisted cable havingvarious gaps and crevices capable of housing bioburdens, water,particles, and other substances therebetween. Further, due to thesurface tension of the twisted cable or wire, water and other particlesmay remain in the gaps and crevices even after a disinfectant isdelivered into the elevator channel. The remaining water or othersubstances contained within the elevator channel may tend to dilute anydisinfectant subsequently delivered into the elevator channel fordisinfection, thereby rendering the process of reducing the bioburdenlevel of the internal channels more difficult. Additionally, thepresence of the cable or wire within the elevator channel creates anadditional restriction as the cable or wire significantly limits thevolume of disinfectant that can flow through the elevator channel.

Ultimately, with an elevator channel having a small diameter and thepresence of a cable or wire contained therein, the challenge to reducethe bioburden level in the endoscope (200) significantly increases.Providing a reprocessing system and method similar to reprocessingsystem (410) and reprocessing method (480) described above, may bedesirable to adequately disinfect the internal channels of an endoscopethrough a recurring cleaning cycle. However, with the enhanceddifficulties in reprocessing elevator channels containing a cable orwire contained therein, it may be desirable for the reprocessing systemand method to utilize disinfectant concentrate during each cycle. Inthis instance, previously used disinfectant is not recycled through thereprocessing system to ensure the concentration of the disinfectant isrelatively high for each recurring cycle to sufficiently increase thebioburden reduction efficacy in the elevator channel of a duodenoscope.

Providing a methodical approach to disinfecting the inner components ofan endoscope may be beneficial to ensure the proper degree of bioburdenreduction is achieved in each instance. The following descriptionprovides various examples of a reprocessing system and method configuredto adequately disinfect the internal channels of an endoscope (200)through a recurring cleaning cycle using concentrated disinfectant foreach cycle. It should be understood that the reprocessing methoddescribed below may be readily incorporated into any of the variousreprocessing systems (2, 310, 310′, 410) and to any of the variousendoscopes (200) described above. Other suitable ways in which thebelow-described reprocessing method may be used will be apparent tothose of ordinary skill in the art in view of the teachings herein.

FIG. 8 shows a block schematic of an exemplary reprocessing system (510)including a disinfectant storage (511), a detergent storage (515), anair supply system (521), and a water supply (525). Except as otherwisedescribed below, reprocessing system (510), disinfectant storage (511),detergent storage (515), air supply system (521), and water reservoir(525) are configured and operable just like reprocessing system (2, 310,310′, 410), disinfectant storage (92, 360, 411), disinfectant storage(86, 415), air supply system (36, 421), and water supply (50, 425),respectively, described above. Internal channels (520) of an endoscope(500) are in fluid communication with disinfectant storage (411),detergent storage (515), air supply system (521) and water reservoir(525) via flush lines (544). Reprocessing system (510) is operable todeliver disinfectant solution (92), detergent solution (86), air andwater to internal channels (520) of endoscope (500) individually andsequentially. While only one endoscope (500) is shown as beingreprocessed in reprocessing system (510), it should be understood thatreprocessing system (510) may be capable of reprocessing more than oneendoscope (500) simultaneously and/or in a sequence.

Flush lines (544) include a flush valve (546) for each channel (520)operatively connected to reprocessing system (510). Flush valves (546)are positioned downstream of disinfectant storage (511), detergentstorage (515), air supply system (521), and water reservoir (525). Inthe present example, disinfectant storage (511) is in fluidcommunication with a disinfectant pump (512), a flow sensor (513) and acheck valve (514) in sequence, such that disinfectant pump (512) isconfigured to transfer disinfectant (92) from disinfectant storage (511)to flow sensor (513) and through check valve (514) via flush lines(544). In this instance, disinfectant solution (92) is a highconcentrate disinfectant or sterilant that is capable of providingadequate bioburden reduction within internal channels (520).

Flow sensor (513) is operable to monitor the flow of concentrateddisinfectant (92) delivered from disinfectant pump (512) to internalchannels (520) of endoscopes (500). Control system (20) of reprocessingsystem (510) is configured to execute a control algorithm (see FIG. 9)to open flush valve (546), which is in fluid connection with endoscope(500), and retrieve the data monitored by flow sensor (513). Controlsystem (20) is operable to terminate fluid communication betweendisinfectant pump (512) and endoscope (500) when the data indicates thatinternal channels (520) have received a sufficient amount ofdisinfectant (92) by closing flush valves (546).

Similarly, detergent storage (515) is in fluid communication with adetergent pump (516), a flow sensor (517) and a check valve (518) insequence, such that detergent pump (516) is configured to transferdetergent solution (86) to flow sensor (517) and through check valve(518) via flush lines (544). Flow sensor (517) is operable to monitorthe elapsed duration as detergent (86) is delivered from detergent pump(516) to internal channels (520) of endoscope (500). In other words,reprocessing system (510) is configured to terminate the fluidcommunication between detergent pump (516) and flush valves (546), byclosing flush valves (546), once the elapsed duration monitored by flowsensor (517) has met a predetermined time threshold for deliveringdetergent (86) to endoscope (500). Alternatively, or in conjunction,reprocessing system (510) is configured to cease operation of detergentpump (516) from pumping detergent (86) to internal channels (520). Ineach instance, reprocessing system (510) is configured to close flushvalves (546) when internal channels (520) have received a sufficientamount of detergent (86) therein, as sensed by flow sensor (517).

Air supply system (521) is in communication with an air pump (522), afilter (523) and a check valve (524). Air pump (522) is configured topush pressurized air from air supply system (521) through filter (523)and check valve (524), thereby delivering a stream of air into andthrough internal channels (520) of endoscope (500). Filter (523) isoperable to filter and remove microbes from the incoming air streamextracted from air supply system (521). In some illustrative examples,filter (523) comprises a HEPA microbe-removing filter. In some versions,reprocessing system (510) may exclude filter (523) in communication withair pump (522) and check valve (524). Water reservoir (525) is in fluidcommunication with a water pump (526), a flow sensor (527) and a checkvalve (528). Water pump (526) is configured to pump water from waterreservoir (525) to flow sensor (527) and through check valve (528) viaflush lines (544).

Reprocessing system (510) is operable to open flush valve (546) and tomeasure the quantity of water delivered from water pump (526) tointernal channels (520) of endoscope (500). Flow sensor (527) isoperable to monitor the quantity of water delivered to internal channels(520). In this instance, reprocessing system (510) is configured toclose flush valve (546) when internal channels (520) have received asufficient amount of water. Reprocessing system (510) further includesbasin (14 a) in fluid communication with internal channels (520) ofendoscope (500) via flush lines (544). Basin (14 a) is operable toreceive any fluids or air released from internal channels (520). Aspreviously mentioned, although not shown, it should be understood thatreprocessing system (510) may include a single pump assembly such thatthe same pump is configured to deliver detergent (86), water,pressurized air, and concentrated detergent (92). In this instance,reprocessing system (510) is configured to selectively open and close aseries of flush valves (546) to individually deliver the varioussubstances with the single pump assembly.

FIG. 9 shows a flow diagram illustrating steps of an exemplaryreprocessing method (580) that may be used by reprocessing system (510)to perform a predetermined number of fill and purge cycles of internalchannels (520) of endoscope (500). At step (582), reprocessing system(510) initiates detergent pump (512) to deliver detergent solution (86)to endoscope (500) via flush lines (544). Reprocessing system (510) isconfigured to deliver detergent (86) through internal channels (520) ata predetermined flow rate. At step (584), as detergent (86) istransferred from detergent storage (515) to endoscope (500), flow sensor(517) measures an elapsed duration of flow as detergent pump (516)actively pumps detergent (86) toward internal channels (520).Reprocessing system (510) ceases operation of detergent pump (516) whenthe elapsed flow time equals a predetermined time threshold fordetergent delivery. Subsequently, at step (586), reprocessing system(510) initiates water pump (526) to deliver water to endoscope (500) viaflush lines (544) and through internal channels (520), to thereby rinseany remaining detergent (86) out from internal channels (520) and intobasin (14 a). In this instance, flow sensor (527) measures an elapsedduration of flow as water pump (526) pumps water into internal channel(520). Reprocessing system (510) ceases operation of water pump (526)when the elapsed flow time equals a predetermined time threshold forrinsing.

At step (588), reprocessing system (510) initiates air pump (522) tosend pressurized air from air supply system (521) through filter (523)and into endoscope (500). The stream of air passes through internalchannels (520) thereby purging internal channels (520) of any residualdetergent (86) or water contained therein. Air pump (522) continues toflow pressurized air through internal channels (520) until a specifiedflow duration elapses signaling for reprocessing system (510) to ceaseoperation of air pump (522). Reprocessing system (510) terminates airpump (522) once the elapsed flow time has reached a predetermined timethreshold for air purging. At step (590), with air pump (522) inactive,disinfectant pump (512) beings to pump high concentrate disinfectant(92) to internal channels (520) of endoscope (500) simultaneously.Reprocessing system (510) monitors the volume of disinfectant (92)transferred from disinfectant storage (511) to endoscopes (500) andceases operation of disinfectant pump (512) when the volume deliveredsubstantially equals a predetermined threshold, as seen at step (592).Reprocessing system (510) closes all flush valves (546) simultaneouswith the deactivation of disinfectant pump (512). In this instance, asseen at step (594), reprocessing system (510) evaluates whether internalchannels (520) of endoscope (500) has stored the high concentratedisinfectant (92) for a minimum dwell time. As merely an illustrativeexample, the predetermined dwell time can range between approximately 10seconds to 30 seconds. Although not shown, it should be understood thatin some versions reprocessing system (510) may forego holding the highconcentrate disinfectant (92) in the internal channels (520) for theminimum dwell time. Instead, flush valves (546) may remain open afterthe deactivation of disinfectant pump (512) and reprocessing system(510) may initiate water pump (526) and air pump (522), respectively insequential order as described above.

At step (596), once reprocessing system (510) has determined thatinternal channels (520) have maintained disinfectant (92) for theminimum dwell time, flush valves (546) are reopened and air pump (522)is reactivated. In this instance, pressurized air is flowed throughinternal channels (520) to thereby purge disinfectant (92) fromendoscope (500). The flow rate of disinfectant (92) being released fromwithin internal channels (520) into basin (14 a) is increased due to theflow of pressurized air, thereby enhancing the bioburden removal. Atstep (598), with disinfectant (92) released into basin (14 a) andcontained therein, reprocessing system (510) determines whether theabove described fill and purge process has been performed predetermined“n” number of times. Upon the determination by reprocessing system (510)that additional fill and purge cycles remain to be completed,reprocessing system (510) will continue to perform step (590) throughstep (598) until reprocessing system (510) determines that no additionalfill and purge cycles remain to be completed. In other words,reprocessing method (580) will proceed to step (599) when reprocessingsystem (510) has performed reprocessing method (580) the predetermined“n” number of times. At step (599), reprocessing system (510) ceasescontinuation of reprocessing method (480).

V. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

EXAMPLE 1

A method for reprocessing an internal channel of at a medical device,the method comprising: (a) activating a first pump to deliver adetergent to the internal channel for a first predetermined duration;(b) activating a second pump to deliver water to the internal channel torinse out the detergent for a second predetermined duration; (c)activating a third pump to deliver pressurized air to the internalchannel to purge out any remaining water or detergent contained withinthe internal channel for a third predetermined duration; (d) activatinga fourth pump to deliver a predetermined volume of disinfectant to theinternal channel; (e) reactivating the third pump to deliver pressurizedair to the internal channel to purge out the disinfectant from theinternal channel into a chamber; (f) reactivating the fourth pump todeliver additional disinfectant to the internal channel; and (g)reactivating the third pump to deliver pressurized air to the internalchannel to purge out the additional disinfectant from the internalchannel into the chamber.

EXAMPLE 2

The method of Example 1, further comprising activating the third pumpafter the first predetermined duration to deliver pressurized air to theinternal channel to purge out the detergent contained within theinternal channel.

EXAMPLE 3

The method of Example 2, further comprising: (a) reactivating the firstpump to deliver additional detergent to the internal channel for a firstpredetermined duration; and (b) reactivating the third pump to deliverpressurized air to the internal channel to purge out the additionaldetergent from the internal channel.

EXAMPLE 4

The method of Example 3, further comprising repeating the acts ofreactivating activating the first pump to deliver additional detergentto the internal channel for a first predetermined duration andreactivating the third pump to deliver pressurized air to the internalchannel to purge out the additional detergent from the internal channeluntil a predetermined number of cycles is met.

EXAMPLE 5

The method of any one or more of Examples 1 through 4, furthercomprising further comprising: (a) reactivating the second pump todeliver additional water to the internal channel for a firstpredetermined duration; and (b) reactivating the third pump to deliverpressurized air to the internal channel to purge out the additionalwater from the internal channel.

EXAMPLE 6

The method of Example 5, further comprising repeating the acts ofreactivating the second pump to deliver additional water to the internalchannel for a first predetermined duration and reactivating the thirdpump to deliver pressurized air to the internal channel to purge out theadditional water from the internal channel until a predetermined numberof cycles is met.

EXAMPLE 7

The method of any one or more of Examples 1 through 6, furthercomprising repeating steps (f) through (g) until a predetermined numberof cycles is met.

EXAMPLE 8

The method of any one or more of Examples 1 through 7, wherein themedical device has a plurality of internal channels, the method furthercomprising repeating steps (a) through (g) for each internal channel ofthe medical device.

EXAMPLE 9

The method of any one or more of Examples 1 through 8, furthercomprising determining a concentration of the disinfectant that isoutput from the chamber.

EXAMPLE 10

The method of any one or more of Examples 1 through 9, furthercomprising monitoring an elapsed duration for delivering the detergent,further comprising deactivating the first pump when the elapsed durationequals the first predetermined duration.

EXAMPLE 11

The method of any one or more of Examples 1 through 10, furthercomprising monitoring an elapsed duration for delivering the water inrelation to the second predetermined duration, further comprisingdeactivating the second pump when the elapsed duration equals the secondpredetermined duration.

EXAMPLE 12

The method of any one or more of Examples 1 through 11, furthercomprising monitoring a volume of disinfectant delivered, furthercomprising deactivating the fourth pump when the volume delivered equalsa capacity of the internal channel.

EXAMPLE 13

The method of any one or more of Examples 1 through 12, furthercomprising filtering microbes from the pressurized air delivered to theinternal channel.

EXAMPLE 14

The method of any one or more of Examples 1 through 13, furthercomprising heating the disinfectant delivered to the internal channel bythe fourth pump.

EXAMPLE 15

The method of any one or more of Examples 1 through 14, furthercomprising circulating a mixture of the disinfectant and the water inthe chamber thereby exposing an outer surface of the medical device tothe mixture.

EXAMPLE 16

The method of Example 15, further comprising continuing the circulationof the mixture for a predetermined time.

EXAMPLE 17

A method for reprocessing an internal channel of at least one medicaldevice, the method comprising: (a) activating a pump assembly to delivera detergent to the internal channel for a first predetermined duration;(b) reactivating the pump assembly to deliver water to the internalchannel to rinse out the detergent for a second predetermined duration;(c) reactivating the pump assembly to deliver pressurized air to theinternal channel to purge out any remaining water or detergent containedwithin the internal channel for a third predetermined duration; (d)reactivating the pump assembly to deliver a predetermined volume ofdisinfectant to the internal channel; (e) reactivating the pump assemblyto deliver pressurized air to the internal channel to purge out thedisinfectant into a chamber; (f) reactivating the pump assembly todeliver a subsequent volume of disinfectant to the internal channel; and(g) reactivating the pump assembly to deliver pressurized air to theinternal channel to purge out the subsequent volume of disinfectant intothe chamber.

EXAMPLE 18

The method of Example 17, further comprising directing the disinfectantin the chamber to the pump assembly.

EXAMPLE 19

The method of Example 17, further comprising repeating (f) through (g)until a predetermined number of cycles is met.

EXAMPLE 20

A medical device reprocessor comprising: (a) a port that is configuredto couple with an internal channel of a medical device; (b) a pumpsystem, wherein the pump system is in fluid communication with adetergent, water, pressurized air, and a disinfectant, wherein the pumpsystem is configured to deliver the detergent to the port, wherein thepump system is further configured to deliver the water to the port,wherein the pump system is further configured to deliver the pressurizedair to the port, wherein the pump system is further configured todeliver the disinfectant to the port; and (c) a control module; whereinthe control module is operable to execute a control algorithm to deliverthe detergent from the pump system to the port and terminate delivery ata first predetermined time threshold; wherein the control module isoperable to execute the control algorithm to deliver the water from thepump system to the port when the first predetermined time threshold ismet and terminate delivery at a predetermined volume threshold; whereinthe control module is operable to execute the control algorithm todeliver the pressurized air from the pump system to the port when thepredetermined volume threshold is met and terminate delivery at a secondpredetermined time threshold; wherein the control module is operable toexecute the control algorithm to deliver the disinfectant from the pumpsystem to the port when the second predetermined time threshold is metand terminate delivery at the predetermined volume threshold; andwherein the control module is configured to repeat the sequentialdelivery of the pressurized air and the disinfectant from the pumpsystem to the port for at least a predetermined number of cycles.

VI. Miscellaneous

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

We claim:
 1. A method for reprocessing an internal channel of at amedical device, the method comprising: (a) activating a first pump todeliver a detergent to the internal channel for a first predeterminedduration; (b) activating a second pump to deliver water to the internalchannel to rinse out the detergent for a second predetermined duration;(c) activating a third pump to deliver pressurized air to the internalchannel to purge out any remaining water or detergent contained withinthe internal channel for a third predetermined duration; (d) activatinga fourth pump to deliver a predetermined volume of disinfectant to theinternal channel; (e) reactivating the third pump to deliver pressurizedair to the internal channel to purge out the disinfectant from theinternal channel into a chamber; reactivating the fourth pump to deliveradditional disinfectant to the internal channel; and (g) reactivatingthe third pump to deliver pressurized air to the internal channel topurge out the additional disinfectant from the internal channel into thechamber.
 2. The method of claim 1, further comprising activating thethird pump after the first predetermined duration to deliver pressurizedair to the internal channel to purge out the detergent contained withinthe internal channel.
 3. The method of claim 2, further comprising: (a)reactivating the first pump to deliver additional detergent to theinternal channel for a first predetermined duration; and (b)reactivating the third pump to deliver pressurized air to the internalchannel to purge out the additional detergent from the internal channel.4. The method of claim 3, further comprising repeating the acts ofreactivating activating the first pump to deliver additional detergentto the internal channel for a first predetermined duration andreactivating the third pump to deliver pressurized air to the internalchannel to purge out the additional detergent from the internal channeluntil a predetermined number of cycles is met.
 5. The method of claim 1,further comprising further comprising: (a) reactivating the second pumpto deliver additional water to the internal channel for a firstpredetermined duration; and (b) reactivating the third pump to deliverpressurized air to the internal channel to purge out the additionalwater from the internal channel.
 6. The method of claim 5, furthercomprising repeating the acts of reactivating the second pump to deliveradditional water to the internal channel for a first predeterminedduration and reactivating the third pump to deliver pressurized air tothe internal channel to purge out the additional water from the internalchannel until a predetermined number of cycles is met.
 7. The method ofclaim 1, further comprising repeating steps (f) through (g) until apredetermined number of cycles is met.
 8. The method of claim 1, whereinthe medical device has a plurality of internal channels, the methodfurther comprising repeating steps (a) through (g) for each internalchannel of the medical device.
 9. The method of claim 1, furthercomprising determining a concentration of the disinfectant that isoutput from the chamber.
 10. The method of claim 1, further comprisingmonitoring an elapsed duration for delivering the detergent, furthercomprising deactivating the first pump when the elapsed duration equalsthe first predetermined duration.
 11. The method of claim 1, furthercomprising monitoring an elapsed duration for delivering the water inrelation to the second predetermined duration, further comprisingdeactivating the second pump when the elapsed duration equals the secondpredetermined duration.
 12. The method of claim 1, further comprisingmonitoring a volume of disinfectant delivered, further comprisingdeactivating the fourth pump when the volume delivered equals a capacityof the internal channel.
 13. The method of claim 1, further comprisingfiltering microbes from the pressurized air delivered to the internalchannel.
 14. The method of claim 1, further comprising heating thedisinfectant delivered to the internal channel by the fourth pump. 15.The method of claim 1, further comprising circulating a mixture of thedisinfectant and the water in the chamber thereby exposing an outersurface of the medical device to the mixture.
 16. The method of claim15, further comprising continuing the circulation of the mixture for apredetermined time.
 17. A method for reprocessing an internal channel ofat least one medical device, the method comprising: (a) activating apump assembly to deliver a detergent to the internal channel for a firstpredetermined duration; (b) reactivating the pump assembly to deliverwater to the internal channel to rinse out the detergent for a secondpredetermined duration; (c) reactivating the pump assembly to deliverpressurized air to the internal channel to purge out any remaining wateror detergent contained within the internal channel for a thirdpredetermined duration; (d) reactivating the pump assembly to deliver apredetermined volume of disinfectant to the internal channel; (e)reactivating the pump assembly to deliver pressurized air to theinternal channel to purge out the disinfectant into a chamber;reactivating the pump assembly to deliver a subsequent volume ofdisinfectant to the internal channel; and (g) reactivating the pumpassembly to deliver pressurized air to the internal channel to purge outthe subsequent volume of disinfectant into the chamber.
 18. The methodof claim 17, further comprising directing the disinfectant in thechamber to the pump assembly.
 19. The method of claim 17, furthercomprising repeating (f) through (g) until a predetermined number ofcycles is met.
 20. A medical device reprocessor comprising: (a) a portthat is configured to couple with an internal channel of a medicaldevice; (b) a pump system, wherein the pump system is in fluidcommunication with a detergent, water, pressurized air, and adisinfectant, wherein the pump system is configured to deliver thedetergent to the port, wherein the pump system is further configured todeliver the water to the port, wherein the pump system is furtherconfigured to deliver the pressurized air to the port, wherein the pumpsystem is further configured to deliver the disinfectant to the port;and (c) a control module; wherein the control module is operable toexecute a control algorithm to deliver the detergent from the pumpsystem to the port and terminate delivery at a first predetermined timethreshold; wherein the control module is operable to execute the controlalgorithm to deliver the water from the pump system to the port when thefirst predetermined time threshold is met and terminate delivery at apredetermined volume threshold; wherein the control module is operableto execute the control algorithm to deliver the pressurized air from thepump system to the port when the predetermined volume threshold is metand terminate delivery at a second predetermined time threshold; whereinthe control module is operable to execute the control algorithm todeliver the disinfectant from the pump system to the port when thesecond predetermined time threshold is met and terminate delivery at thepredetermined volume threshold; and wherein the control module isconfigured to repeat the sequential delivery of the pressurized air andthe disinfectant from the pump system to the port for at least apredetermined number of cycles.